R-Biopharm RIDAGENE CMV PG9005 Bedienungsanleitung Seite 39

(urine only) and MagNA Pure 96 (Roche), and they were amplified using LightCycler
480II (Roche). The results are summarized in Table 11.
Table 11: Diagnostic sensitivity of RIDA
®
Maxwell RSC
Samples
Urine positive for CMV
MagNA Pure 96
Samples
Plasma (EDTA) positive for
CMV
Urine positive for CMV
13.1.2 Diagnostic specificity
The diagnostic specificity of the RIDA
confirmation of negative clinical specimen material, was confirmed using CMV-
negative clinical specimens. Negative plasma and urine specimens (predetermined
using another real-time PCR method) were extracted using Maxwell
(urine only) and MagNA Pure 96 (Roche), and they were amplified using LightCycler
480II (Roche). The results are summarized in Table 12.
Table 12: Diagnostic specificity of RIDA
®
Maxwell RSC
Samples
Urine negative for CMV
MagNA Pure 96
Samples
Plasma (EDTA) negative for CMV 50
Urine negative for CMV

RIDA GENE CMV
®
GENE CMV
N
46
N
50
47
®
GENE CMV real-time PCR test, defined as
®
GENE CMV
N
53
N
56
2019-05-28
Positive
46
Positive
50
47
Positive
5
Positive
5
6
®
Negative
0
Negative
0
0
®
RSC (Promega)
®
Negative
48
Negative
45
50
39